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Thursday, 14 September 2017
Page: 10426

Mr HUNT (FlindersMinister for Health and Minister for Sport) (10:21): I move:

That this bill be now read a second time.

1. Introduction

Australians rely on medicines and medical devices to prevent, treat or cure their illnesses, injuries and conditions. The Therapeutic Goods Administration (TGA), as regulator, enables the therapeutic goods available in Australia to be of an acceptable safety, quality and efficacy and that the latest therapeutic advances are available to the Australian public when they need them.

The Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 builds on recent amendments to the Therapeutic Goods Act 1989 to support the continued implementation of the government's response to the Expert Panel Review of Medicines and Medical Devices Regulation.

The review assessed the regulatory framework for medicines and medical devices in Australia, providing a number of recommendations aimed to position the TGA to effectively respond to the increasing globalisation of the therapeutic goods industry, expectations from patients that they should have access to new medicines and medical devices at the same time as their peers in Europe and North America, and to the rapid pace of innovation in the development of health products. It is imperative that we update the regulatory framework for medicines and medical devices in Australia, ensuring it remains in a position to continue to support the availability of high quality, safe and efficacious products in a timely way to the community.

2. Summary of the bill

This bill, therefore, provides for:

establishing a provisional approval scheme so patients can have earlier access to highly promising new medicines in cases where they address an unmet clinical need—it comes directly from the agreement with Medicines Australia;

making changes to the regulation of complementary medicines that will allow consumers to make more informed product choices;

introducing reforms to streamline the advertising framework for therapeutic goods so that consumers will be better informed about the medicines and other healthcare products they buy; and

improved compliance and monitoring provisions to strengthen consumer protections.

This bill will build on the recent changes enacted through the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017.

2.1 Provisional approval pathway

First, this bill will establish a provisional approval pathway for certain promising new prescription medicines. This would allow Australian patients with currently inadequate treatment options to access potentially life-saving or life-transforming medicines up to two years earlier than under the current framework. It builds on similar approaches available to patients in Europe and North America.

Such medicines would be registered on the basis of early clinical data which provides promising evidence that the medicine is likely to be a major therapeutic advance for Australian patients.

Provisional registration will be time limited and subject to strict conditions imposed by the TGA, including the requirement to collect more data to confirm the clinical benefit and safety of the medicine, and there will be specific communications with patients and healthcare professionals about these medicines. A number of enhancements to the TGA's post-market monitoring scheme are being implemented in parallel. These do not require further legislative changes, but will be important to monitor the safety of provisionally registered medicines.

I particularly want to thank both the TGA and the leadership of Medicines Australia, chaired by Wes Cook, and led at CEO level by Milton Catelin, for their input, involvement and engagement in the Medicines Australia agreement and compact with the government. These changes are a result of their collaborative and cooperative work. I want to acknowledge and thank them for that.

2.2 Use of overseas assessments for medical devices

In addition, in relation to the use of overseas assessments for medical devices, what we will see is that medical devices will also potentially reach the market sooner through the greater use of overseas amendments afforded by this bill. Under the amendments, the work of comparable overseas regulators will be accepted as evidence when determining whether a medical device should be included on the Australian Register of Therapeutic Goods. Provision of an additional pathway for seeking approval for inclusion in the register provides the potential for faster access to market for industry and therefore earlier access of innovative devices to address specific needs of patients.

2.3 Advertising

Furthermore, to strengthen the regulation of advertising of medicines and medical devices, while also reducing regulatory burden, this bill will overhaul the current structure for therapeutic goods advertising into a more streamlined framework.

Industry will no longer have to navigate an often complex co-regulatory system which has incomplete coverage, as it requires only some medicine advertisements to be approved prior to publication or broadcast.

Similarly, advertising complaints can be heard by multiple bodies and currently take many months or longer to resolve. Instead, the shift will be to a single, centralised complaint handling system managed by the TGA, and enhanced enforcement and compliance powers to deter inappropriate or misleading advertising of therapeutic goods. This will be supported by better education and guidance for advertisers, to encourage greater understanding of and compliance with the advertising regulatory framework.

2.4 Compliance powers

In terms of the fourth area of compliance powers, to further protect consumers, this bill looks to strengthen and broaden the current range of investigation and enforcement powers under the act. It has done so in conjunction with support from the sector. Powers relating to monitoring, investigation, infringement notices and injunctions will be standardised to align with comparable Commonwealth regulators and contemporary government policy.

The changes will allow for a graduated approach to compliance and enforcement and provide the TGA with a full suite of sanctions and penalties to protect public health—this includes such things as more ready use of infringement notices for minor offences while at the same time providing the regulator with the ability to seek a court injunction for more serious matters.

2.5 Complementary medicines

The fifth element here is that the reforms to the complementary medicines regulatory framework will also lead to increased information on the products and stronger protections for consumers. This bill provides for a list of permitted indications from which industry sponsors must exclusively select when entering a listed complementary medicine on the Australian Register of Therapeutic Goods.

Only low-level, pre-approved claims will be permitted for these products.

This bill will also provide sponsors of listed complementary medicines with a new assessment pathway that bridges the gap between existing listed and registered complementary medicines. Sponsors will have the option of utilising this pathway for indications that address more than the most minor of conditions. Under this pathway, the TGA will assess the evidence of efficacy that supports the proposed indication and make a decision whether or not to approve the complementary medicine product for the market.

Complementary medicines assessed via this new pathway will be eligible to contain information on the packaging and advertising material to indicate that the product has been assessed by the TGA for the approved indication. This new pathway is intended to encourage greater development of evidence relating to complementary medicines; increase consumer confidence in the evidence around product efficacy; and improve effectiveness of the sector.

3. Other changes from the Review

A number of other recommendations from the review, which are being implemented without the need for legislative changes, also aim to strengthen consumer protections.

3.1 Better reporting of adverse events

In addition, the TGA will create a means for more efficient reporting and analysis of adverse events, work with other stakeholders to analyse electronic data to detect adverse events, and have the powers to inspect companies to check that they have systems for timely action on adverse event reports for their products.

3.2 SME Assist

A further initiative to encourage innovation has been the establishment of SME Assist, which I launched on 9 June 2017. SME Assist provides targeted tools and content to help small and medium enterprises and research and development groups developing new medicines.

The bill contains, therefore, a number of other supporting amendments which are intended to provide consistency across the different types of therapeutic goods.


Ultimately, the overwhelming stakeholder support for these reforms is evident from the many consultations undertaken—from the initial stages of the review, through to consultations on options and the exposure draft of the bill.

I particularly want to thank:

Medicines Australia

the Generic and Biosimilar Medicines Association

the Pharmacy Guild of Australia

the Pharmaceutical Society of Australia

Complementary Medicines Australia

the Australian Self Medication Industry, and

the Medical Technology Association of Australia.

The changes outlined in this bill, coupled with the recent amendments already enacted, will strengthen Australia's therapeutic goods regulatory framework, ensuring it remains well positioned to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods.

This is our opportunity to make significant reforms to the regulation of therapeutic goods in Australia—reforms that will ensure better access to medicines, streamlined administrative processes and stronger consumer protections; reforms that will ensure Australia remains at the forefront of therapeutic goods regulation, now and into the future.

I especially want to thank Alex Best, from my office, and the head of the TGA, Professor John Skerritt, and I commend this bill to the House.

Debate adjourned.